Aloglip12.5 mg

Aloglip is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Established (FDA-approved) uses

• As monotherapy when diet and exercise alone do not provide adequate glycemic control.
• As combination therapy with metformin, a sulfonylurea, pioglitazone, or insulin (with or without metformin) when the current regimen, plus diet and exercise, does not provide adequate glycemic control.

Not indicated for

• Treatment of type 1 diabetes mellitus.
• Treatment of diabetic ketoacidosis.

Aloglip is not a substitute for insulin in patients who require insulin therapy and should not be used for weight loss or as a first-line agent in place of lifestyle modification.

Each tablet contains Alogliptin Benzoate equivalent to alogliptin base, commonly available in strengths of 6.25 mg, 12.5 mg, and 25 mg, along with pharmaceutically acceptable excipients.

Aloglip is the benzoate salt of alogliptin, an orally active, highly selective inhibitor of the enzyme dipeptidyl peptidase-4 (DPP-4). It belongs to the class of antidiabetic medicines known as gliptins, used in the management of type 2 diabetes mellitus.

Aloglip works by prolonging the activity of incretin hormones, which help the body release insulin appropriately after meals and reduce excess glucose production by the liver.

Aloglip belongs to the therapeutic class of oral antidiabetic agents, specifically the dipeptidyl peptidase-4 (DPP-4) inhibitor class, also known as "gliptins."

Alogliptin Benzoate works by inhibiting the DPP-4 enzyme, which is responsible for the rapid breakdown of the incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide).

Mechanism

• By inhibiting DPP-4, Alogliptin Benzoate increases the concentration of active incretin hormones.
• This leads to increased glucose-dependent insulin secretion from pancreatic beta cells.
• It also decreases inappropriate glucagon secretion from pancreatic alpha cells, reducing hepatic glucose output.
• These effects are glucose-dependent, meaning the insulinotropic effect diminishes as blood glucose approaches normal levels, which lowers the intrinsic risk of hypoglycemia when used alone.

Pharmacokinetics

• Absorption: Peak plasma concentration of Alogliptin Benzoate occurs approximately 1 to 2 hours after oral administration; food does not significantly affect absorption.
• Metabolism: Alogliptin Benzoate undergoes minimal hepatic metabolism; the majority of the dose is eliminated unchanged.
• Excretion: Primarily excreted unchanged in the urine via renal (tubular secretion and glomerular filtration) pathways, with an elimination half-life of approximately 21 hours, supporting once-daily dosing.

Aloglip tablets should be swallowed whole with water, with or without food, at approximately the same time each day. It should not be crushed or chewed unless otherwise directed by a physician.

Aloglip has a low potential for clinically significant drug interactions because it is not extensively metabolized by the cytochrome P450 enzyme system and is not a major substrate, inhibitor, or inducer of most CYP isoenzymes or P-glycoprotein.

Clinically significant interactions

• Insulin and insulin secretagogues (sulfonylureas): Concomitant use with Aloglip increases the risk of hypoglycemia. A lower dose of the sulfonylurea or insulin may be required when combined with Aloglip.
• Other antidiabetic agents (metformin, pioglitazone): No dose adjustment of Aloglip is required, but blood glucose should be monitored when combining agents.
• Drugs affecting renal function: Because Aloglip is primarily renally eliminated, caution is advised when co-administering with drugs that significantly reduce renal function, as this may necessitate dose adjustment of Aloglip.

No dose adjustment of Aloglip is needed with warfarin, digoxin, or oral contraceptives based on available pharmacokinetic data.

Most patients tolerate Aloglip well. Side effects are generally mild, but some can be serious and require prompt medical attention.

Common side effects

• Headache
• Upper respiratory tract infection (nasopharyngitis)
• Diarrhea and other mild gastrointestinal upset

Serious side effects (seek medical attention)

• Acute pancreatitis: Persistent, severe abdominal pain, sometimes radiating to the back, with or without vomiting, has been reported. Aloglip should be discontinued promptly if pancreatitis is suspected.
• Heart failure: An increased risk of hospitalization for heart failure has been observed with Aloglip, particularly in patients with pre-existing heart or kidney disease. Signs include unusual shortness of breath, rapid weight gain, or swelling of the ankles/feet.
• Severe joint pain (arthralgia): Can occur at any time during treatment with Aloglip and may be disabling.
• Bullous pemphigoid: A rare, serious blistering skin condition has been reported with Aloglip and requires discontinuation and dermatologic evaluation.
• Hypersensitivity reactions: Including anaphylaxis, angioedema, and severe skin reactions such as Stevens-Johnson syndrome.
• Hepatic effects: Rare cases of liver failure, sometimes fatal, have been reported with Aloglip.

Pregnancy

There are limited human data on the use of Aloglip in pregnant women. Aloglip should be used during pregnancy only if clearly needed and the potential benefit to the mother justifies the potential risk to the fetus. Because uncontrolled hyperglycemia during pregnancy carries risks, a physician should be consulted to weigh options, and insulin is generally the preferred agent for glycemic control in pregnancy.

Lactation

It is not known whether Aloglip is excreted in human breast milk. Because many drugs are excreted in human milk, caution should be exercised when Aloglip is administered to a breastfeeding woman, and a physician should be consulted before use during breastfeeding.

Before starting Aloglip, inform the physician of any history of pancreatitis, gallstones, alcohol use, high triglycerides, heart failure, kidney disease, or liver disease.

• Pancreatitis: Discontinue Aloglip promptly if pancreatitis is suspected (see Side Effects).
• Heart failure: Use Aloglip with caution in patients with risk factors for heart failure; monitor for signs of fluid retention (see Side Effects).
• Hypoglycemia: Risk is increased when Aloglip is combined with insulin or a sulfonylurea; dose adjustment of the other agent may be required (see Interactions).
• Renal impairment: Dose of Aloglip must be adjusted based on renal function (see Dosage and Administration).
• Hepatic impairment: Use Aloglip with caution; rare hepatic failure has been reported (see Side Effects).
• Skin reactions: Discontinue Aloglip and seek evaluation for any severe skin reaction, blistering, or signs of bullous pemphigoid.
• Aloglip should be taken exactly as prescribed by a physician; do not stop, skip, or alter the dose without medical advice, and regular blood glucose and HbA1c monitoring is recommended during treatment.

In case of a suspected overdose of Aloglip, seek immediate medical attention or contact a poison control center/emergency services. In clinical studies, single doses of Aloglip up to 800 mg were generally well tolerated. Management of overdose involves supportive treatment, monitoring of vital signs and clinical status, and hemodialysis may remove a modest amount of Aloglip if clinically indicated. Do not attempt to manage a suspected overdose at home without professional medical guidance.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Renal Impairment

Dose adjustment of Aloglip is required based on the degree of renal impairment (see Dosage and Administration). Aloglip has not been studied in patients on peritoneal dialysis.

Hepatic Impairment

No dose adjustment of Aloglip is needed in mild to moderate hepatic impairment; use in severe hepatic impairment is not recommended (see Dosage and Administration).

Elderly

No overall differences in safety or effectiveness of Aloglip were observed between elderly and younger patients, though greater sensitivity in some older individuals cannot be ruled out; renal function should be assessed before and during treatment.

Pediatric Use

Safety and efficacy of Aloglip have not been established in patients under 18 years of age (see Pediatric Uses).

Aloglip is generally used long-term as part of ongoing management of type 2 diabetes mellitus. It should be continued for as long as the prescribing physician determines it is providing adequate glycemic control, with periodic reassessment of HbA1c, renal function, and overall treatment response. Aloglip should not be stopped abruptly without medical advice, as this may lead to worsening blood glucose control.

Alogliptin Benzoate belongs to the DPP-4 inhibitor (gliptin) class of oral antidiabetic medications.

Alogliptin Benzoate selectively inhibits the DPP-4 enzyme, thereby increasing levels of active incretin hormones (GLP-1 and GIP), which enhances glucose-dependent insulin secretion and suppresses excess glucagon release, resulting in improved blood glucose control in type 2 diabetes mellitus.

B

The safety and efficacy of Aloglip have not been established in pediatric patients under 18 years of age. Aloglip is therefore not recommended for use in children or adolescents, and its use should be limited to adult patients with type 2 diabetes mellitus.